Kornimate/medical-research-clean huggingface dataset:
clinical and biological characteristics of hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: hidradenitis suppurativa (hs) is a common and debilitating skin disease that is poorly understood and understudied. as a result, little is known about disease prognosis and few effective treatments exist for this condition. this prospective observational cohort study aims to comprehensively characterize the clinical and biological features of hs. the results of this research will provide a basis for the development of an hs clinical classification system and identification of potential treatments for hs.


Eligibility criteria:
hidradenitis suppurativa patients inclusion criteria: 1. age 13 years or older 2. diagnosis of hs clinically-confirmed by a physician exclusion criteria: 1. inability to give informed consent or have a parent/guardian who is able and willing to give informed consent. healthy volunteer inclusion criteria: 1. no history of chronic skin conditions 2. no recent history of antibiotic use exclusion criteria: 1. inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.
sstap vs tap catheters in tah

Conditions: Postoperative Pain

Summary: prospective, randomized study comparing local wound infiltration with local anesthetic (la) versus single injection tap blocks (sstap) with la versus continuous tap block (tap caths) catheters with la for treatment of postoperative pain after total abdominal hysterectomy (tah).


Eligibility criteria:
inclusion criteria: * scheduled to undergo total abdominal hysterectomy * age ≥ 18 years. * american society of anesthesiologists (asa) physical status ≤ 3 exclusion criteria: * known coagulopathy * known allergy to bupivacaine or morphine * contraindication to tylenol usage * medical conditions contraindicated to bupivacaine use * daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.
phase iii study comparing the efficacy and safety of ep2006 and filgrastim

Conditions: Chemotherapy Associated Neutropenia; Breast Cancer

Summary: the study will assess the efficacy of ep2006 compared to filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.


Eligibility criteria:
inclusion criteria: 1. patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy 2. women ≥ 18 years of age 3. estimated life expectancy of more than six months exclusion criteria: 1. previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry 2. any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: filgrastim g-csf, neutropenia supportive care breast cancer
robotic assisted versus laparoscopic cholecystectomy - outcome and cost analyses of a case-matched control study

Conditions: Cholecystolithiasis

Summary: case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (da vinci robot, intuitive surgical). these patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, asa score, histology and surgical experience. * trial with surgical intervention

cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. surprisingly, data is lacking regarding patient outcome or associated costs compared to the use of conventional laparoscopic surgery. the study is designed to assess the potential benefits of robotic-assisted cholecystectomy. to achieve a high level of evidence we chose a prospective case matched controlled methodology. three experienced and one junior (2nd yr) surgeon are involved, and were fully trained with the robot prior to initiating the study including tasks in a training box on pig livers and 5 cholecystectomies performed on humans with this technology. each patient operated with the robotic system is retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy. the robotic assisted operations are performed with the 3- arm da vinci robot system (da vinci robot, intuitive surgical). similar to the laparoscopic technique an additional fourth trocar was used to retract the gallbladder. the positioning (french) of the patients and the trocars are also comparable to the conventional laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * cholecystectomy due to symptomatic cholecystolithiasis * acute or chronic cholecystitis exclusion criteria: * patients \< 18 years * primary open cholecystectomy
adapt and incorporate ddpp into clinical workflows

Conditions: Physician-Patient Relations; Nurse-Patient Relations

Summary: this observational study will seek to adapt a digital diabetes prevention program (ddpp) tool suite into clinical workflows. this tool pushes key ddpp data elements (e.g. weight and daily step count) directly into ehr workflows of primary care to enhance patient engagement. it seeks to determine the impact of combining adapted visualizations and summaries of key ddpp data elements directly into the ehr with automated notifications and messaging designed to enhance patient engagement in the ddpp. the study will involve provider workflow analysis based on observation and facilitated group tool adaptation sessions.

primary objective: to examine the impact of the ddpp tool suite on the ehr and clinical workflows, and identify optimization opportunities. secondary objective: to assess the "usability" of the proposed ddpp tool suite in clinical practice.

Eligibility criteria:
inclusion criteria: * physicians * nurses * practice assistants * health coaches * population health managers * patient navigators exclusion criteria: * practices will be ineligible for participation if they treat fewer than 100 adults with prediabetes.

Keywords: physicians nurses practice assistants health coaches population health managers patient navigators
surgical management of postpartum haemorrhage without embolization

Conditions: Postpartum Hemorrhage; Second Line Management; Uterine Arteries Embolization; Surgical Management of Haemorrhage

Summary: postpartum haemorrhage is the main cause of maternal mortality. the aim of investigators' study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.


Eligibility criteria:
inclusion criteria: * age over 18 * postpartum haemorrhage * necessity of second line management * no embolization performed * necessity of surgical management after embolization exclusion criteria: * unnecessity of second line management * management by only embolization * incomplete medical files

Keywords: embolization surgery hysterectomy arterial ligation
pharmacokinetic of ceftriaxone in septic icu patients

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: ceftriaxone pharmacokinetics variability in intensive care unit septic patients in intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients. however, pharmacokinetic alterations have been described for some drugs used in intensive care units. these alterations, consequences of alteration of volume of distribution, of protein concentrations, of impaired hepatic and renal functions can result in accumulation with toxicity or " under dosage " with inefficacity. ceftriaxone is an antibiotic often prescribed in intensive care unit. however, despite this large utilisation, very few data is available on the pharmacokinetic in intensive care unit, and optimal dosage is not known. our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive care unit patients with sepsis, severe sepsis and septic shock and to identify the " data " explaining interindividual variability of each pharmacokinetics parameter.

this is a one centre population pharmacokinetics non interventional study. one group of 50 patients allows the development of the model and a second group of 20 patients will be used for the validation of the model. septic patients treated with ceftriaxone according to standard procedure of our icu could be included before the second administration of the drug. in the development group, patients will underwent five determination of serum concentration of ceftriaxone during the 24 hours following the second administration. the timing of samples will be randomised in three groups. a second phase of sampling will take place during the fifth day of ceftriaxone therapy for sepsis and severe sepsis patients and after 48 hours catecholamine- free for septic shock patients. for the validation group, ten samples will be obtained at the same periods. this study will not induce any change in the care of patients. samples will be centrifugated immediately after collection and conserved at - 20 °c. ceftriaxone will be assayed in the department of pharmacology, university of marseille france, usig hplc method. pharmacokinetic analysis will used nonlinear mixed effects modelling logiciel

Eligibility criteria:
inclusion criteria: * eighteen-year or more * sepsis, severe sepsis or septic shock (according to bone's criteria) * admission to intensive care unit * informed consent obtained * affiliation to medicare exclusion criteria: * previous haemodialysis * hemopathy * known allergy to cephalosporin * patients whose death is considered imminent

Keywords: sepsis ceftriaxone pharmacokinetic intensive care unit
gene expression in hyperparathyroidism

Conditions: Parathyroid Disease; Hyperparathyroidism

Summary: objectives: 1. to better define the differences in molecular genetics of parathyroid tumors in patients with men1, single gland parathyroid disease in patients less than 50 years old and single gland disease in patients greater than 50 years old. 2. to better define the incidence of hrpt2 mutation in young patients with primary hyperparathyroidism and determine whether routine testing in these patients is indicated.

patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports. archived formalin-fixed paraffin-embedded (ffpe) tissue blocks from surgical specimens of patients will be stained for parafibromin to evaluate for hrpt2 mutations.

Eligibility criteria:
inclusion criteria: 1. all patients previously enrolled in parathyroid tissue banking under protocol lab08-0034. 2. for the subgroup designated for hrpt2 mutation testing: patients with primary hyperparathyroidism who are younger than 50 years of age and have tested negative for men1, between january 1, 1980 and the present. exclusion criteria: n/a

Keywords: parathyroid disease hyperparathyroidism chart review men1-negative hrpt2 mutations
hstnt after elective coronary angiography

Conditions: Coronary Artery Disease

Summary: a prospective study, aiming to understand and analyse the key role of the novel high sensitivity troponin t (hstnt) within a group of patients undergoing an uncomplicated coronary angiography without receiving any additional intervention. the peri-procedural elevation of the hstnt indicates some other factors being responsible for the elevation of the hstnt in absence of an acute coronary syndrome, such as physiological components or micro-injuries. a one year follow-up has been collected.


Eligibility criteria:
inclusion criteria: - stable or unknown cad exclusion criteria: - acute coronary syndrome

Keywords: prei-procedural elevation cardia troponin t in stable unknown
longitudinal study of neurodegenerative disorders

Conditions: MLD; Krabbe Disease; ALD; MPS I; MPS II; MPS III; Vanishing White Matter Disease; GM3 Gangliosidosis; PKAN; Tay-Sachs Disease; NP Deficiency; Osteopetrosis; Alpha-Mannosidosis; Sandhoff Disease; Niemann-Pick Diseases; MPS IV; Gaucher Disease; GAN; GM1 Gangliosidoses; Morquio Disease; S-Adenosylhomocysteine Hydrolase Deficiency; Batten Disease; Pelizaeus-Merzbacher Disease; Leukodystrophy; Lysosomal Storage Diseases; Purine Nucleoside Phosphorylase Deficiency; Multiple Sulfatase Deficiency Disease

Summary: the purpose of this study is to understand the course of rare genetic disorders that affect the brain. this data is being analyzed to gain a better understanding of the progression of the rare neurodegenerative disorders and the effects of interventions.

patients would be evaluated by a multidisciplinary team at specific time points every 3 months the first year, every 6 months the second year and once a year thereafter.

Eligibility criteria:
inclusion criteria: * any patient with a genetic neurodegenerative disorder exclusion criteria: * none

Keywords: pediatric rare neurodegenerative genetic neurodevelopment brain mri biorepository ndrd longitudinal cognitive motor language adaptive behavior
18f-floretyrosine expanded access program

Conditions: Glioma (Any Grade) in the Brain

Summary: the aim of this expanded access program (eap) is to enable the use of 18f-floretyrosine with positron emission tomography/computed tomography (pet/ct) or positron emission tomography/magnetic resonance (pet/mr) imaging to noninvasively detect tumor burden or treatment related change to assist in optimal management of patients with glioma.


Eligibility criteria:
inclusion criteria: 1. written and voluntarily given informed consent. pediatric patients (\<18 years of age) will provide assent along with parental/legal guardian /caregiver consent according to irb requirements. 2. male or female ≥ 3 years of age at time of consent/assent 3. diagnosis or clinical suspicion of glioma (any grade) in the brain 4. at the time of screening have undergone therapy for glioma 5. indeterminate mr findings for disease recurrence or progression versus treatment related changes (pseudoprogression or pseudoresponse) requiring further diagnostic procedures within 60 days prior to the 18f-floretyrosine pet imaging 6. willing and able to lie still for at least 40 minutes in an enclosed space for the imaging procedure, or if medically necessary, able to tolerate standard institutions procedures for sedation and/or anesthesia. exclusion criteria: 1. participant cannot be safely scanned due to devices, implants, foreign and/or metallic objects in or on the body that are not mr compatible, unless a clinical judgement is made that the participant's diagnostic needs can instead be met by diversion to 18f-floretyrosine imaging by pet/ct (making the magnetic field compatibility an irrelevant safety concern). 2. women who are pregnant or breastfeeding. 3. women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of the program (day 0 to day 2). 4. serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the participant, as judged by the investigator. 5. mental impairment that may compromise the ability to give informed consent/assent and comply with the requirements of the program as judged by the investigator. 6. exposure to any experimental diagnostic or therapeutic drug within 30 days from the date planned administration of 18f-floretyrosine. 7. known hypersensitivity to floretyrosine or tyrosine derivatives. 8. unable to tolerate the program procedures.
study to determine if gloving in addition to hand hygiene will prevent invasive infections and necrotizing enterocolitis

Conditions: Neonatal Infection; Neonatal Necrotizing Enterocolitis

Summary: the purpose of this study is to compare the additional use of gloves (with handwashing before and after gloving) for all patient contact while infants have intravenous (central or peripheral) access in a rct. preterm infants \<1000 grams or less than 29 weeks gestational age will be randomized after birth to either a handwashing-gloving group or handwashing only group. the primary outcome will be the incidence of invasive infections (bacterial or fungal) or necrotizing enterocolitis. secondary outcomes will include hospital days, preterm morbidities, mortality, and hospital costs.

all infants who had a birth weight of less than or equal to 1000 grams or who were born less than 29 weeks gestation were eligible for this study. 120 subjects were randomized by day of life(dol) 8 to one of two study groups--hand hygiene or hand hygiene plus gloving. study signs were placed at the bedside and on the isolette sides of each infant with the appropriate study group guidelines. the investigators goal was to target the time period these infants are at high-risk for infection or nec and its associated mortality. the targeted time was the first 4 weeks of life or longer while intravenous access is still required. the average age for the first episode of late-onset sepsis is 22(+/-0.5) days (median: 17 days; 75th percentile: 28 days; 95th percentile: 57 days). the majority of infections that occur after 4 weeks of life are in patients still requiring iv access (peripheral or central). the presence of an intravenous line in this group of preterm infants correlates with the presence of risk factors for infection that would necessitate the need for intravenous access including: parenteral nutrition, lipid infusion, use of broad spectrum antibiotics, and the intravenous line itself (if it is a central venous catheter). this strategy focused on the individual infant's risks, limits exposure to and decreases cost of intervention.

Eligibility criteria:
inclusion criteria: * birth weight \<1000 grams or gestational age ≤28 weeks * less than or equal to 7 days of age exclusion criteria: * greater than 7 days of age

Keywords: prematurity infection control necrotizing entercolitis
a continued access protocol to provide xolair to patients with severe allergic asthma

Conditions: Asthma

Summary: this is a continued access protocol to provide subjects who have completed genentech, inc. study q2143g, q2195g, or q2461g or novartis pharmaceuticals corporation study cige025 0010e1 with continued xolair treatment. subject eligibility will be based on disease severity and asthma deterioration upon withdrawal of xolair treatment. subjects whose last xolair dose was \<9 months prior to screening visit will continue with the same xolair dosing regimen that they received in the previous genentech or novartis clinical study.


Eligibility criteria:
inclusion criteria: * completion of genentech study q2143g, q2195g, or q2461g or novartis study cige025 0010e1 * signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative) * females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study. * severe asthma as demonstrated by at least one of the following: \*history of prior intubation for allergic asthma; \*history of prior admission to an intensive care unit/pediatric icu for asthma; \*history of one or more hospitalizations, emergency room (er) visits, or unscheduled office visits for asthma in the 12 months prior to first xolair treatment; \*more than 20 days missed from school/work because of allergic asthma in the 12 months prior to initiation of xolair treatment * deterioration of asthma upon withdrawal of xolair as demonstrated by meeting at least one of the following: \*worsening of pulmonary function tests (fev1 \<80% predicted for height, age, and sex) and activity levels while off xolair treatment; \*worsening of asthma exacerbations defined as doubling of inhaled steroid dose, increase in dose of oral steroids, or initiation of oral, intravenous, intramuscular, or subcutaneous (sc) steroids while off xolair treatment; \*increased use of rescue medications while off xolair treatment; \*er visits or unscheduled office visits for asthma that may or may not result in hospitalization while off xolair treatment exclusion criteria: * pregnancy or lactation * significant systemic disease (e.g., hematologic, renal, hepatic, coronary heart, endocrine, gastrointestinal disease, other cardiovascular diseases, or infection) within the previous 3 months * history of neoplasia (including basal cell carcinoma) * any systemic condition requiring regular administration of an immunoglobulin * known hypersensitivity to any ingredients of xolair, including excipients (sucrose, histidine, polysorbate 20) * current treatment with warfarin (coumadin(r)), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy * current participation in a study using an investigational new drug other than xolair

Keywords: allergic asthma severe allergic asthma
vitiligo severity, quality of life, work productivity and activity impairment

Conditions: Vitiligo

Summary: translate and validate the vitiligo specific quality of life (vitiqol) questionnaire to arabic language. evaluate the effect of vitiligo on patient quality of life using vitiligo specific quality of life questionnaire (vitiqol). measure the impact of vitiligo on work productivity using work productivity and activity impairment questionnaire (wpai) and general self efficacy scale (gse) . analyze how disease severity and location influence patients quality of life and work pro

vitiligo is a common disorder of depigmentation caused by the progressive destruction of melanocytes that affect the skin, hair and mucous membranes, clinically presenting as depigmented macules and leukotrichia. vitiligo was historically regarded as a cosmetic disorder; however, it is an immune disease as it affects patient well-being . it affects approximately 0.5-1% of the global population. a study reported a prevalence of 1.2% in the egyptian population. vitiligo is asymptomatic disease, so its effect on quality of life is much more related to psychological problems, such as lack of self-confidence unpleasant body images unsuccessful social relationships, and lower quality of marital relations, than the exclusive physical issues. it has been shown that patients with vitiligo are at risk of higher social discrimination and stigma lesions that are more severe, on the face, or covering a greater bsa are more often associated with poorer outcomes and activity impairment. recently a study conducted in egypt in 2023 noted that more than half of studied sample had low level of self-esteem and quality of life. while more than half of studied sample had moderate negative body image. also, half of studied sample had moderate level of social problems . limited studies have been conducted in upper egypt which assess life quality of patients with vitiligo and but those studies employed non-specific tools like dermatology life quality index (dlqi). lilly et al have developed a reliable tool with high internal consistency named as vitiligo specific quality of life questionnaire(vitiqol) that consists of 16 questions comprising of demographic and clinical parameters of the patients. also the work productivity and activity impairment among vitiligo patients in egypt have not been assessed before .

Eligibility criteria:
inclusion criteria: * adults \> 18 years and less than 60 years old diagnosed with vitiligo by a physician patients willing to complete the survey questionnaires patients who can speak arabic exclusion criteria: * patients with other major skin disease affecting qol . patient with chronic diseases as diabetes mellitus and hypertension not working patients